NCT03119077 - Single Ascending Dose, First-in-Human Study on Safety, Tolerability and Pharmacokinetics of BAY1161116 | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

April 27, 2017

Primary Completion Date

September 8, 2017

Study Completion Date

January 31, 2018

Conditions

Polycystic Ovary Syndrome

Interventions

DRUG

BAY1161116

Escalating doses of BAY1161116; single dose administration; redosing of BAY1161116 at dose group 1 together with itraconazole; redosing of BAY1161116 at dose group 2 as liquid service formulation, redosing of BAY1161116 at dose group 3 together with food

DRUG

Placebo

Escalating doses of respective placebos; single dose administration; redosing of placebo at dose group 1 together with itraconazole; redosing of placebo at dose group 2 as liquid service formulation, redosing of placebo at dose group 3 together with food

DRUG

Itraconazole

Redosing of BAY1161116/placebo at dose group 1 together with itraconazole

Trial Locations (1)

13353

CRS Clinical Research Services Berlin GmbH, Berlin